Effects of Inhaled Epinephrine on Systemic Allergic Reactions During Allergy Testing Immunotherapy or Oral Challenges

A Phase 1b Open-Label Exploratory Study Evaluating Inhaled Epinephrine in Individuals With Known or Suspected Metabisulfite Sensitivity Experiencing Systemic Allergic Reactions During Allergy Testing Immunotherapy or Oral Challenges

The purpose of this exploratory study is to evaluate the effects of inhaled epinephrine in patients with known or suspected metabisulfite sensitivity who experience a systemic allergic reaction (SAR) while undergoing allergy testing, immunotherapy or oral challenges.

Study Overview

• Status: Completed
• Conditions: Hypersensitivity; Anaphylaxis
• Intervention / Treatment: Drug: Inhaled Epinephrine

Detailed Description

This is a Phase 1b, single-center, open label exploratory study that will evaluate the effects of inhaled epinephrine in patients with known or suspected metabisulfite sensitivity and who are undergoing planned allergy testing, subcutaneous immunotherapy (SCIT), oral challenges (food and/or drug), or oral immunotherapy (OIT). This study will enroll and dose up to 60 patients.

The maximum duration of subject participation is approximately 1 week.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Richmond, British Columbia, Canada, V7C 5L9
      • 1232176 Bc Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Males or females, aged ≥ 18 years with known or suspected metabisulfite sensitivity who can also have a clinical history of immunoglobulin E (IgE)-mediated allergy, including a documented sensitivity to allergens (i.e., positive skin prick test, or positive in vitro serum IgE).
2. Have undergone either a) allergy testing for suspected sensitivity/allergy, b) oral challenge (food and/or drug), c) oral immunotherapy (OIT) to treat existing allergies or d) subcutaneous immunotherapy (SCIT) following a prior allergic reaction AND experiences a systemic allergic reaction (SAR) rated as Grade ≥2, following allergy testing, SCIT, oral challenge (food and/or drug), or OIT, and deemed eligible for enrollment by the Principal Investigator.
3. For females of child-bearing potential, not pregnant or lactating, willing to use a highly effective method of birth control between Screening and End-of-Study Visits.

Exclusion Criteria:

1. Known reaction or sensitivity to epinephrine or any of the ingredients of inhaled epinephrine.
2. Known history or presence of clinically relevant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurological, psychological or other disease/condition that could confound the results of the study or place the subject at undue or additional risk per the judgment of the Investigator.
3. Uncontrolled asthma or chronic obstructive pulmonary disease (COPD).
4. Recent life-threatening asthma within the last 6 months which required admission to hospital prior to study start.
5. Use of any tobacco or of any inhaled products, including vaping and water pipes (Hookahs) within 12 months prior to screening and/or a 10 pack per year history of use.
6. Use of antihistamines within 5 days and/or bronchodilators within 24 hours of pre-challenge visit.
7. Surgical procedures within 90 days of screening that could result in confounding of results or additional risk to the subject, per the judgment of the Investigator.
8. Abnormal vital signs at screening (i.e., systolic blood pressure: < 90 or >140 mmHg, diastolic blood pressure: < 40 or > 90 mmHg or, Heart rate: < 45 or > 100 bpm), respiration rate < 8 or > 20 resp./min.
9. Females who are pregnant, plan to become pregnant or lactating.
10. Participation in another clinical study involving an investigational drug within 30 days prior to screening, an investigational biologic within 60 days prior to screening, or current/planned participation in another interventional study during this study.
11. Previous treatment in this study.
12. Any other reason that, in the opinion of the Investigator, is likely to unfavourably alter subject risk-benefit, confound results, or make it difficult for the subject to fully comply with study requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Inhaled Epinephrine; The first inhalation will be administered as soon as possible (i.e., within approximately 30 seconds) following identification of a Grade 2 or greater SAR and confirmation of enrollment by the Principal Investigator. The second inhalation will be administered approximately 10 seconds later, and the subject will be observed for approximately 2 minutes for signs of symptom resolution. Inhalations will continue in this manner until either: resolution of systemic symptoms (defined as a reduction in SAR Grade to ≤1), or; maximum number of inhalations (8 inhalations) is reached, or; administration of intra-muscular epinephrine, whichever occurs earlier

Drug: Inhaled Epinephrine; 0.125 mg per inhalation. The maximum proposed dose to be administered is 1.0 mg (consisting of 8 inhalations of 0.125 mg over 6 minutes).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to resolution of systemic symptoms.	Defined as a reduction in systemic allergic reaction (SAR) Grade to ≤ 1.	From first dose administration to 60 minutes following first dose administration.

Collaborators and Investigators

• Sponsor: Dr. George Luciuk
• Investigators: Principal Investigator: George H. Luciuk, MD, Kokua Pharma Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Actual): April 8, 2025
• Study Completion (Actual): April 8, 2025

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Hypersensitivity; Immunotherapy; Epinephrine; Anaphylaxis; Adrenergic alpha-Agonists; Hypersensitivity, immediate; Adrenergic beta-Agonists; Upper airway laryngeal edema; Upper airway pharyngeal edema; Vasoconstrictor agents; Bronchodilator agents
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Anaphylaxis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Epinephrine
• Other Study ID Numbers: GHL-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data collected during the trial, after deidentification
• IPD Sharing Time Frame: Immediately after publication, and for a period of 5 years.
• IPD Sharing Access Criteria: Any purpose. URL to be added.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes